21 USC 1605 - Procedures for dismissal of civil actions against biomaterials suppliers

U.S Code last checked for updates: Nov 22, 2024

§ 1605.

Procedures for dismissal of civil actions against biomaterials suppliers

(a)

Motion to dismiss

A defendant may, at any time during which a motion to dismiss may be filed under applicable law, move to dismiss an action against it on the grounds that the defendant is a biomaterials supplier and one or more of the following:

(1)

The defendant is not liable as a manufacturer, as provided in section 1604(b) of this title.

(2)

The defendant is not liable as a seller, as provided in section 1604(c) of this title.

(3)

The defendant is not liable for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in section 1604(d) of this title.

(4)

The claimant did not name the manufacturer as a party to the action, as provided in subsection (b).

(b)

Manufacturer of implant shall be named a party

In any civil action covered by this chapter, the claimant shall be required to name the manufacturer of the implant as a party to the action, unless—

(1)

the manufacturer is subject to service of process solely in a jurisdiction in which the biomaterials supplier is not domiciled or subject to a service of process; or

(2)

a claim against the manufacturer is barred by applicable law or rule of practice.

(c)

Proceeding on motion to dismiss

The following rules shall apply to any proceeding on a motion to dismiss filed by a defendant under this section:

(1)

Effect of motion to dismiss on discovery

(A)

In general

(B)

Discovery

If a defendant files a motion to dismiss under subsection (a)(3) on the grounds that it did not furnish raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, the court may permit discovery limited to issues that are directly relevant to—

(i)

the pending motion to dismiss; or

(ii)

the jurisdiction of the court.

(2)

Affidavits

(A)

Defendant

(B)

Claimant

In response to a motion to dismiss, the claimant may submit affidavits demonstrating that—

(i)

the Secretary has, with respect to the defendant and the implant that allegedly caused harm to the claimant, issued a declaration pursuant to section 1604(b)(2)(B) of this title; or

(ii)

the defendant is a seller of the implant who is liable under section 1604(c) of this title.

(3)

Basis of ruling on motion to dismiss

The court shall rule on a motion to dismiss filed under subsection (a) solely on the basis of the pleadings and affidavits of the parties made pursuant to this subsection. The court shall grant a motion to dismiss filed under subsection (a)—

(A)

unless the claimant submits a valid affidavit that demonstrates that the defendant is not a biomaterials supplier;

(B)

unless the court determines, to the extent raised in the pleadings and affidavits, that one or more of the following apply:

(i)

the defendant may be liable as a manufacturer, as provided in section 1604(b) of this title;

(ii)

the defendant may be liable as a seller, as provided in section 1604(c) of this title; or

(iii)

the defendant may be liable for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in section 1604(d) of this title; or

(C)

if the claimant did not name the manufacturer as a party to the action, as provided in subsection (b).

(4)

Treatment of motion as motion for summary judgment

(d)

Summary judgment

(1)

In general

(A)

Basis for entry of judgment

(B)

Issues of material fact

(2)

Discovery made prior to a ruling on a motion for summary judgment

(3)

Discovery with respect to a biomaterials supplier

(e)

Dismissal with prejudice

(f)

Manufacturer conduct of litigation

(Pub. L. 105–230, § 6, Aug. 13, 1998, 112 Stat. 1526.)

cite as: 21 USC 1605